Durvalumab and Olaparib in Metastatic or Recurrent Endometrial Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The DOMEC trial is designed as a Dutch Gynecological Oncology Group (DGOG), prospective, multi-center, phase II study for 55 patients with advanced (recurrent, refractory or metastatic) endometrial cancer or carcinosarcoma of the uterus to investigate the efficacy of the combination therapy of olaparib tablets and durvalumab IV.
详细描述
The prognosis of recurrent or persistent endometrial carcinoma not amenable to local therapy is poor. First line therapy exists of platinum-based chemotherapy or hormonal therapy. No standard subsequent-line therapy has been described.The combination of Poly(ADP-ribose) polymerases (PARP) inhibition and Programmed death-ligand 1 (PD-L1) blocking has great potential in the treatment of recurrent endometrial cancer. The DOMEC trial is designed to investigate this treatment combination among all molecular subgroups.
The DOMEC trial is designed as a DGOG, prospective, multi-center, phase II study for 55 patients with advanced (recurrent, refractory or metastatic) endometrial cancer, including carcinosarcoma of the uterus. Patients must have had one prior platinum-based chemotherapeutic regimen or not be able/willing to get chemotherapy. The aim is to investigate the efficacy of the combination therapy of olaparib tablets 300mg twice daily orally and durvalumab 1500mg by IV infusion every 4 weeks in terms of progression free survival. Secondary objectives are to investigate objective response rate, overall survival, safety and predictive biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PARP inhibitor and Anti-PD-L1
olaparib tablets 300mg twice daily orally and durvalumab 1500mg by IV infusion every 4 weeks
干预措施: PARP inhibitor and Anti-PD-L1 (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 6 months
PFS will be counted from the date of registration until the first observation of radiological progressive disease according to RECIST 1.1 criteria or death due to any cause, whichever occurred first.
次要结局
- Objective response rate (ORR)(12 weeks)
- Overall survival (OS)(Through study completion, up to 36 months)
- Adverse events(Through study completion, up to 36 months)
- Predictive biomarkers in tumor biopsy(At baseline)
研究者
J.R. Kroep
Principal Investigator
Leiden University Medical Center